Tolerability Pharmacokinetics and Efficacy of ZSP1603 in Patients With Idiopathic Pulmonary Fibrosis IPF

  • STATUS
    Recruiting
  • End date
    Oct 21, 2022
  • participants needed
    36
  • sponsor
    Guangdong Raynovent Biotech Co., Ltd
Updated on 24 November 2021
idiopathic pulmonary fibrosis
diffusion capacity of the lung for carbon monoxide

Summary

This study was divided into two parts. The first part was a dose escalation study: a open label dose escalation design was used to evaluate the safety, tolerance and pharmacokinetic characteristics of ZSP1603 in IPF patients. The second part was a randomized double-blind placebo-controlled design was used to preliminatively investigate the efficacy and safety of ZSP1603 in the treatment of IPF at the target dose.

Details
Condition Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, usual interstitial pneumonia
Treatment Placebo, ZSP1603
Clinical Study IdentifierNCT05119972
SponsorGuangdong Raynovent Biotech Co., Ltd
Last Modified on24 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

IPF diagnosed, according to 2018 American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management
Dlco (corrected for Hb): 30%-79% predicted of normal
FVC>= 50% predicted of normal

Exclusion Criteria

FEV1/FVC< 0.7
PaO2 in resting state without oxygen inhalation < 50mmHg
Subjects who were likely to be lung transplant recipients or expected to survive less than 1 year during the study period as assessed by the investigator
Poorly controlled cardiovascular and cerebrovascular diseases
Patients who had used nidanib, pirfenidone, interferon, n-acetylcysteine, azathioprine, cyclophosphamide, cyclosporine, prednisone > 15mg/ day (or equivalent dose of other glucocorticoids) within 4 weeks before enrollment; Those who had used Chinese herbal medicine or acupuncture treatment within 1 week before enrollment
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